Patent application title: MOLDED CONTAINER WITH RAISED NIPPLE AND METHOD FOR USE

Abstract:

This invention container comprises a container shell comprising a body
portion, adjoining cap portion and enclosed stopper, and an engineered
separation site to facilitate separation of body and cap. The stopper has
a raised nipple on the stopper, positioned such that a portion of the
stopper is enclosed within the body portion and a portion of the stopper
is enclosed within the cap portion. When the cap portion is removed from
the body portion, a portion of the nipple therefore extends out of the
body portion, allowing easy access to the stopper for cleaning or
contents removal. In addition, there is an engineered separation site
which includes a partial attenuation of the thickness of part of the
container wall. Raised gussets are provided to enhance the cooperation
between the instant invention and various needle-free connectors known in
the art.

Claims:

1. A container (10) with at least one diameter (12) and a longitudinal
axis (14), comprising:a) a container shell (50) comprising a body portion
(200) with a body portion wall (220) having a wall shoulder portion (221)
having a distal aspect (222) and a proximal aspect (223) and an adjoining
cap portion (300) having a cap portion wall (320), wherein the body
portion wall (220) meets the cap portion wall (320) at an engineered
separation site (400); andb) a stopper (100) enclosed within the
container shell (50) and preventing the transfer of contents from the
body portion (200) to the cap portion (300), such that a portion of the
stopper (100) is enclosed within the body portion (200) and a portion of
the stopper (100) is enclosed within the cap portion (300), wherein the
stopper (100) has a stopper wall (120) and a stopper shoulder (123) with
a central raised nipple (130) having a nipple top surface (134) with an
injection site (135) bounded by a raised injection guide (136) and a
nipple sidewall (132), and wherein the engineered separation site (400)
is adjacent to the nipple sidewall (132) such that when the cap portion
(300) is removed from the body portion (200) at the engineered separation
site (400) a portion of the nipple (130) extends out of the body portion
(200).

2. The container of claim 1 wherein the wall shoulder portion (221)
adjacent to the cap portion (300) is configured at a non-orthogonal angle
from the longitudinal axis (14) of the container (10).

3. The container of claim 2 wherein the body portion wall (220) has an
ingress preventer (224), wherein said ingress preventer (224) cooperates
with a stopper ingress preventer (124) formed in the stopper wall (120).

6. The container of claim 5 wherein the wall shoulder portion (221)
further comprises at least one raised gusset (228) extending from the
wall shoulder portion (221) and having a lateral surface (229)
substantially parallel to the longitudinal axis (14) of the container
(10).

7. The container of claim 6 wherein said lateral surface (229) begins at
the distal aspect (222) of the wall shoulder portion (221) and extends
substantially parallel to the longitudinal axis (14) of the container at
least 25% of the longitudinal distance from the distal aspect (222) to
the injection site (135) measured along the longitudinal axis (14) of the
container (10).

8. The container of claim 7 wherein the lateral surface (229) begins at
the distal aspect (222) of the wall shoulder portion (221) and extends
substantially parallel to the longitudinal axis (14) of the container at
least 50% of the longitudinal distance from the distal aspect (222) to
the injection site (135) measured along the longitudinal axis (14) of the
container (10).

9. The container of claim 8 wherein the cap portion wall (320) is formed
with a grip enhancing feature (330).

10. The container of claim 9 wherein the grip enhancing feature (330) is a
flattened tab (332) having a lateral aspect (333).

11. The container according to claim 1 which additionally comprises an
engineered separation site (400) which is a line of discontinuity in
shell thickness between the body portion wall (220) and the cap portion
wall (320).

12. The container of claim 11 wherein the engineered separation site (400)
is formed by a progressive attenuation of the thickness of the wall
shoulder portion (221) tapering from a maximum thickness at the distal
aspect (222) of the wall shoulder portion (221) to reach a minimum
thickness at the proximal aspect (223) of the wall shoulder portion
(221).

13. A container (10) with at least one diameter (12) and a longitudinal
axis (14), comprising:a) a container shell (50) comprising a body portion
(200) with a body portion wall (220) having a wall shoulder portion (221)
configured at a non-orthogonal angle from the longitudinal axis (14) of
the container (10) having a distal aspect (222) and a proximal aspect
(223) wherein the wall shoulder portion (221) further comprises at least
one raised gusset (228) extending from the wall shoulder portion (221)
and having a lateral surface (229) substantially parallel to the
longitudinal axis (14) of the container (10) wherein the lateral surface
(229) begins at the distal aspect (222) of the wall shoulder portion
(221) and extends substantially parallel to the longitudinal axis (14) of
the container at least 25% of the longitudinal distance from the distal
aspect (222) to the injection site (135) measured along the longitudinal
axis (14) of the container (10), and an adjoining cap portion (300)
having a cap portion wall (320), wherein the body portion wall (220)
meets the cap portion wall (320) at an engineered separation site (400)
wherein the engineered separation site (400) comprises a line of
discontinuity in shell thickness between the body portion wall (220) and
the cap portion wall (320) formed by a progressive attenuation of the
thickness of the wall shoulder portion (221) tapering from a maximum
thickness at the distal aspect (222) of the wall shoulder portion (221)
to reach a minimum thickness at the proximal aspect (223) of the wall
shoulder portion (221); andb) a stopper (100) enclosed within the
container shell (50) and preventing the transfer of contents from the
body portion (200) to the cap portion (300), such that a portion of the
stopper (100) is enclosed within the body portion (200) and a portion of
the stopper (100) is enclosed within the cap portion (300), wherein the
stopper (100) has a stopper wall (120) and a stopper shoulder (123) with
a central raised nipple (130)) having a nipple top surface (134) with an
injection site (135) and a nipple sidewall (132), and wherein the
engineered separation site (400) is adjacent to the nipple sidewall (132)
such that when the cap portion (300) is removed from the body portion
(200) at the engineered separation site (400) a portion of the nipple
(130) extends out of the body portion (200).

15. A container (10) with at least one diameter (12) and a longitudinal
axis (14), comprising:a) a container shell (50) comprising a body portion
(200) with a body portion wall (220) having a wall shoulder portion (221)
configured at a non-orthogonal angle from the longitudinal axis (14) of
the container (10) having a distal aspect (222) and a proximal aspect
(223) wherein the wall shoulder portion (221) further comprises at least
one raised gusset (228) extending from the wall shoulder portion (221)
and having a lateral surface (229) substantially parallel to the
longitudinal axis (14) of the container (10) wherein the lateral surface
(229) begins at the distal aspect (222) of the wall shoulder portion
(221) and extends substantially parallel to the longitudinal axis (14) of
the container at least 25% of the longitudinal distance from the distal
aspect (222) to the injection site (135) measured along the longitudinal
axis (14) of the container (10), and an adjoining cap portion (300)
having a cap portion wall (320) formed with a grip enhancing feature
(330) the grip enhancing feature (330) is a flattened tab (332) formed
such that a distance from a most distant point on the tab (332) from a
center of the injection site (135) is at least 65% of the largest of the
at least one diameter (12) of the container (10), wherein the body
portion wall (220) meets the cap portion wall (320) at an engineered
separation site (400) wherein the engineered separation site (400)
comprises a line of discontinuity in shell thickness between the body
portion wall (220) and the cap portion wall (320) formed by a progressive
attenuation of the thickness of the wall shoulder portion (221) tapering
from a maximum thickness at the distal aspect (222) of the wall shoulder
portion (221) to reach a minimum thickness at the proximal aspect (223)
of the wall shoulder portion (221); andb) a stopper (100) enclosed within
the container shell (50) and preventing the transfer of contents from the
body portion (200) to the cap portion (300), such that a portion of the
stopper (100) is enclosed within the body portion (200) and a portion of
the stopper (100) is enclosed within the cap portion (300), wherein the
stopper (100) has a stopper wall (120) and a stopper shoulder (123) with
a central raised nipple (130)) having a nipple top surface (134) with an
injection site (135) and a nipple sidewall (132), and wherein the
engineered separation site (400) is adjacent to the nipple sidewall (132)
such that when the cap portion (300) is removed from the body portion
(200) at the engineered separation site (400) a portion of the nipple
(130) extends out of the body portion (200).

16. The container of claim 15 wherein the lateral surface (229) begins at
the distal aspect (222) of the wall shoulder portion (221) and extends
substantially parallel to the longitudinal axis (14) of the container at
least 50% of the longitudinal distance from the distal aspect (222) to
the injection site (135) measured along the longitudinal axis (14) of the
container (10).

17. A method for storing and dispensing a flowable substance within a
container, according to claim 1.

Description:

TECHNICAL FIELD

[0001]The invention relates to the field of molded containers,
particularly to a blow-fill-seal (BFS) vial containing an internal
elastomeric stopper, where the elastomeric stopper has a raised nipple
that projects beyond the outer shell of the vial.

BACKGROUND OF THE INVENTION

[0002]Small vials with elastomeric stoppers are traditionally used to
contain small amounts of liquids, particularly liquid medications, or as
storage and dispensing vessels for lyophilized medications that are
reconstituted prior to use. Safe retention of the elastomeric stopper
requires a foil over-cap, to prevent the expulsion of the stopper should
pressure within the vial rise. Additionally, the elastomeric stoppers
generally require siliconization as a lubricant to insert the stoppers in
the vials during the manufacturing process, thus introducing a
potentially additional chemical compound. Furthermore, glass vials are
inherently liable to breakage. In the end, a stoppered glass vial
requires at least three different structural compounds (glass,
elastomers, and foil), and assembly requires numerous steps.

[0003]More recently, large advances have been made in molded plastic
containers, often referred to as "blow-fill-seal" or "BFS" containers. As
is well known in the art, resin is extruded and molded into a container,
and the container is then filled and the resin container sealed, all is a
series of automated steps, generally carried out in a continuous or
near-continuous process in a sterile environment within the BFS molding
machinery. The evolution of this method of packaging is also well known
in the art. Initially, various methods were described for blow molding a
hollow thermoplastic article; for example, as seen in U.S. Pat. Nos.
3,137,748 and 3,288,898. More complex process for manufacturing BFS
containers are later seen in U.S. Pat. Nos. 3,464,085 and 3,597,793. A
further evolutionary step, by way of example only is seen in U.S. Pat.
No. 3,919,374; which enabled the addition of an elastomeric stopper to a
BFS vial. More recently, methods have been taught, as in U.S. Pat. No.
4,707,966; for molding a flat bottomed thermoplastic container, filling
the container from the top, and then, prior to sealing, effecting a
secondary operation, such as positioning an insert such as an elastomeric
stopper in the top opening of the container, and then partially or
completely encapsulating the insert in such a way that the encapsulating
portion of the material can easily be broken away to gain access.

[0004]The BFS manufacturing process traditionally includes sub-components
such as a thermoplastic polymer storage and feeding system; an extruder
with a parison head; a sterile air filling chamber; a specialized mandrel
capable of filling the container, mold halves capable of opening and
closing, and therein forming the container; and various downstream items
of equipment, such as inspection and leak detection systems, labelers,
and packaging machinery.

[0005]Aseptic processing equipment, such as tanks fitted with sterility
filters, ensures that the BFS machinery is continuously provided with
sterile product. Thermoplastic polymer granules are typically fed via a
vacuum tubing system into a hopper in the blow-fill-seal extruder, where
they are heated to form a melt, typically at about 215° C. The
thermoplastic polymer melt is formed via a circular orifice into a
plastic parison (hollow tube), which is held open by a stream of sterile
filtered air. The lower part of the divided mold halves then close to
seal the bottom of the open parison and the parison wall is blown and/or
compressed by vacuum to the cooled mold walls to form the lower part of
the BFS container. A filling mandrel fills a predetermined quantity of
product into the container, and after withdrawal of the mandrel, the
upper portion of the mold closes to form and seal the upper part of the
BFS container. For BFS vials with encapsulated stoppers or other inserts,
an intermediate step includes placement of the insert in the correct
position prior to encapsulation as part of the BFS process. Since
multiple cavities may be built within a single mold, the rate of
production is substantially related to the number of cavities in each BFS
mold.

[0006]Vials with encapsulated stoppers generally resemble the type of
prior art construction as illustrated in FIG. 1. There are a number of
problems with such a construction. Firstly, the relatively right angle
shoulder where the encapsulated thermoplastic turns over the top of the
stopper creates an area that is difficult to blow mold. Secondly, the
need for a reproducible fracture area wherein the vial may be opened
requires a weakened area for such a fracture area, which can be difficult
to design into such packaging. Lastly, the designs, owing to the fact
that the stopper is encapsulated within the thermoplastic shell, result
in a stopper surface that lies below the level of the shell. Thus, when
opened, the exposed surface of the stopper essentially lies in a hole,
surround by a raised thermoplastic area, as seen in FIG. 2. This can make
access to the stopper, such as for cleaning and disinfection difficult.
As taught below, the instant invention overcomes these and many other
shortcomings of contemporary BFS vial design.

SUMMARY OF INVENTION

[0007]In its most general configuration, the present invention advances
the state of the art with a variety of new capabilities and overcomes
many of the shortcomings of prior devices in new and novel ways. The
present invention is a molded container having a raised nipple, formed
according to the traditional blow-fill-seal (BFS) methods described
above. The container comprises a cap portion, a body portion, and with an
encapsulated stopper.

[0008]The body portion has a body portion wall having a wall shoulder
portion with a distal aspect and a proximal aspect. The body portion has
an adjoining cap portion such that the body portion wall meets a cap
portion wall at an engineered separation site, designed to represent an
area of weakness in the walls of the container.

[0009]The container has a stopper enclosed within the container shell that
prevents the transfer of contents from the body portion to the cap
portion. A portion of the stopper is enclosed within the body portion and
a portion of the stopper is enclosed within the cap portion. The stopper
has a stopper wall and a stopper shoulder with a central raised nipple
having a nipple top surface with an injection site and a nipple sidewall.
The engineered separation site is adjacent to the nipple sidewall such
that when the cap portion is removed from the body portion at the
engineered separation site, a portion of the nipple extends out of the
body portion.

[0010]This projection of a part of the nipple beyond the body portion
presents numerous advantages over the prior art. When the cap of a
traditionally formed BFS a vial is removed, the surface of the stopper
lies essentially in a hole formed by the surrounding BFS shell. Thus, to
clean the surface, it is necessary to place a cleaning means into the
hole, hoping that the means will reach and adequately clean the surface
of the stopper. Additionally, the relatively small hole means that the
operator has only a very small surface area to hit with the needle, or
other removal means, used to puncture the stopper and access the
container contents.

[0011]The instant invention allows all of the top surface of the nipple to
be easily cleaned, if desired, and allows substantially all of the top
surface of the nipple to be accessed by a needle, or other removal means,
to puncture the stopper and access the container contents.

[0012]The body wall shoulder portion, adjacent to the cap portion, may be
configured at a non-orthogonal angle from the longitudinal axis of the
container. This also has numerous advantages over the prior art,
including but not limited to the following. It can be difficult, when the
body wall should of a BFS vial comprises an orthogonal angle, to insure
sufficient plastic at the bend to form a sufficiently strong container.
Additionally, such a right-angle bend imposes a geometry that makes
design of a suitable breakage line between the body and the cap of a BFS
vial more difficult.

[0013]In another embodiment, the wall shoulder portion further comprises
at least one raised gusset, extending from the wall shoulder portion and
having a lateral surface substantially parallel to the longitudinal axis
of the container. Such gusset(s) not only tend to strengthen the BFS
vial, but cooperate with a variety of connectors.

[0014]Extending the length of the lateral surface increases the surface
area of interaction between the container and the interior surface of a
needle-free container, and a larger surface area for interaction results
in a more stable cooperation between the elements and a more positive
centering of a needle-free connector.

[0015]To assist in the separation of the cap portion and the body portion,
the cap portion may have a cap portion wall formed with a grip enhancing
feature such as a flattened tab (332), see FIGS. 13(a) and 13(b). Various
embodiments employing different geometries maybe useful in facilitating
the opening of the container, which is often of a relatively small size.
Such a flattened tab may have relatively short lateral expanse such that
the easiest means of removing the cap portion from the body portion is to
use two hands, one to grip the body portion and another to twist off the
cap portion. While one-handed removal of the cap portion in such a design
is not impossible, it may require a degree of hand strength not
universally found among those desiring to use the container.

[0016]The hand strength required for one-handed opening may be decreased
by increasing the moment arm of the tab, that is, the larger the tab
relative to the container, the less force that must be applied at a
distal point on the tab to effect a rupture at the engineered separation
site. This allows easier removal of the cap portion from the body portion
by torquing the cap portion. Such relative elongation of the tab simply
increases the leverage available for opening the container at the
engineered separation site.

[0017]Clean and accurate removal of the cap portion from the body portion
may also be facilitated by refinements in the engineered separation site
where the body portion wall meets the cap portion wall. In one embodiment
of the instant invention, the engineered separation site comprises a line
of discontinuity in shell thickness between the body portion wall and the
cap portion wall. The discontinuity creates a natural fracture zone
between the adjoining body portion and cap portion. In a further
embodiment, the engineered separation site is formed by a progressive
attenuation of the thickness of the wall shoulder portion tapering from a
maximum thickness at the distal aspect of the wall shoulder portion to
reach a minimum thickness at the proximal aspect of the wall shoulder
portion (221), see FIG. 7. Variations, modifications, alternatives, and
alterations of the various preferred embodiments may be used alone or in
combination with one another, as will become more readily apparent to
those with skill in the art with reference to the following detailed
description of the preferred embodiments and the accompanying figures and
drawings.

[0018]There is disclosed a container (10) with at least one diameter (12)
and a longitudinal axis (14), comprising a container shell (50)
comprising a body portion (200) with a body portion wall (220) having a
wall shoulder portion (221) having a distal aspect (222) and a proximal
aspect (223) and an adjoining cap portion (300) having a cap portion wall
(320), wherein the body portion wall (220) meets the cap portion wall
(320) at an engineered separation site (400); and a stopper (100)
enclosed within the container shell (50) and preventing the transfer of
contents from the body portion (200) to the cap portion (300), such that
a portion of the stopper (100) is enclosed within the body portion (200)
and a portion of the stopper(100) is enclosed within the cap portion
(300), wherein the stopper (100) has a stopper wall (120) and a stopper
shoulder (123) with a central raised nipple (130) having a nipple top
surface (134) with an injection site (135) bounded by a raised injection
guide (136) and a nipple sidewall (132), and wherein the engineered
separation site (400) is adjacent to the nipple sidewall (132) such that
when the cap portion (300) is removed from the body portion (200) at the
engineered separation site (400) a portion of the nipple (130) extends
out of the body portion (200). Further, there is disclosed a container
(10) with at least one diameter (12) and a longitudinal axis (14),
comprising a container shell (50) comprising a body portion (200) with a
body portion wall (220) having a wall shoulder portion (221) configured
at a non-orthogonal angle from the longitudinal axis (14) of the
container (10) having a distal aspect (222) and a proximal aspect (223)
wherein the wall shoulder portion (221) further comprises at least one
raised gusset (228) extending from the wall shoulder portion (221) and
having a lateral surface (229) substantially parallel to the longitudinal
axis (14) of the container (10) wherein the lateral surface (229) begins
at the distal aspect (222) of the wall shoulder portion (221) and extends
substantially parallel to the longitudinal axis (14) of the container at
least 25% of the longitudinal distance from the distal aspect (222) to
the injection site (135) measured along the longitudinal axis (14) of the
container (10), and an adjoining cap portion (300) having a cap portion
wall (320), wherein the body portion wall (220) meets the cap portion
wall (320) at an engineered separation site (400) wherein the engineered
separation site (400) comprises a line of discontinuity in shell
thickness between the body portion wall (220) and the cap portion wall
(320) formed by a progressive attenuation of the thickness of the wall
shoulder portion (221) tapering from a maximum thickness at the distal
aspect (222) of the wall shoulder portion (221) to reach a minimum
thickness at the proximal aspect (223) of the wall shoulder portion (221)
and a stopper (100) enclosed within the container shell (50) and
preventing the transfer of contents from the body portion (200) to the
cap portion (300), such that a portion of the stopper (100) is enclosed
within the body portion (200) and a portion of the stopper (100) is
enclosed within the cap portion (300), wherein the stopper (100) has a
stopper wall (120) and a stopper shoulder (123) with a central raised
nipple (130)) having a nipple top surface (134) with an injection site
(135) and a nipple sidewall (132), and wherein the engineered separation
site (400) is adjacent to the nipple sidewall (132) such that when the
cap portion (300) is removed from the body portion (200) at the
engineered separation site (400) a portion of the nipple (130) extends
out of the body portion (200). Further, there is disclosed a container
(10) with at least one diameter (12) and a longitudinal axis (14),
comprising a container shell (50) comprising a body portion (200) with a
body portion wall (220) having a wall shoulder portion (221) configured
at a non-orthogonal angle from the longitudinal axis (14) of the
container (10) having a distal aspect (222) and a proximal aspect (223)
wherein the wall shoulder portion (221) further comprises at least one
raised gusset (228) extending from the wall shoulder portion (221) and
having a lateral surface (229) substantially parallel to the longitudinal
axis (14) of the container (10) wherein the lateral surface (229) begins
at the distal aspect (222) of the wall shoulder portion (221) and extends
substantially parallel to the longitudinal axis (14) of the container at
least 25% of the longitudinal distance from the distal aspect (222) to
the injection site (135) measured along the longitudinal axis (14) of the
container (10), and an adjoining cap portion (300) having a cap portion
wall (320) formed with a grip enhancing feature (330) the grip enhancing
feature (330) is a flattened tab (332) formed such that a distance from a
most distant point on the tab (332) from a center of the injection site
(135) is at least 65% of the largest of the at least one diameter (12) of
the container (10), wherein the body portion wall (220) meets the cap
portion wall (320) at an engineered separation site (400) wherein the
engineered separation site (400) comprises a line of discontinuity in
shell thickness between the body portion wall (220) and the cap portion
wall (320) formed by a progressive attenuation of the thickness of the
wall shoulder portion (221) tapering from a maximum thickness at the
distal aspect (222) of the wall shoulder portion (221) to reach a minimum
thickness at the proximal aspect (223) of the wall shoulder portion
(221); and a stopper (100) enclosed within the container shell (50) and
preventing the transfer of contents from the body portion (200) to the
cap portion (300), such that a portion of the stopper (100) is enclosed
within the body portion (200) and a portion of the stopper (100) is
enclosed within the cap portion (300), wherein the stopper (100) has a
stopper wall (120) and a stopper shoulder (123) with a central raised
nipple (130)) having a nipple top surface (134) with an injection site
(135) and a nipple sidewall (132), and wherein the engineered separation
site (400) is adjacent to the nipple sidewall (132) such that when the
cap portion (300) is removed from the body portion (200) at the
engineered separation site (400) a portion of the nipple (130) extends
out of the body portion (200).

BRIEF DESCRIPTION OF THE DRAWINGS

[0019]Without limiting the scope of the present invention as claimed below
and referring now to the drawings and figures, all not to scale:

[0020]FIG. 1 is a cross section view of an embodiment of a prior art
molded container;

[0021]FIG. 2 is a cross section view of a prior art molded container with
a cap portion removed;

[0022]FIG. 3 is a side elevation view of an embodiment of the instant
invention;

[0023]FIG. 4 is a cross section view of the cap portion and a part of a
body portion of the present invention;

[0024]FIG. 5 is a cross section view of a part of the body portion of the
embodiment of the instant invention of FIG. 4, with the cap portion
removed;

[0025]FIG. 6 is a cross section view of a stopper of the instant
invention;

[0026]FIG. 7 is a cross section view of the cap portion, the stopper, and
a part of the body portion of another embodiment of the molded container
of the instant invention;

[0027]FIG. 8 is a cross section view of a part of the body portion of the
embodiment of FIG. 5, and a needle-free connector;

[0028]FIG. 9a is a cross section view showing potential misalignment
between the body portion of the embodiment of FIG. 5, and a needle-free
connector;

[0029]FIG. 9b is a top plan view of an embodiment of the instant
invention, showing raised gussets extending from a wall shoulder portion;

[0030]FIG. 10 is a cross section view of a part of the body portion of the
BFS vial and a needle-free connector;

[0031]FIG. 11 is a cross section view of a part of the body portion of the
embodiment of the instant invention with the needle-free connector
inserted;

[0032]FIG. 12a is a top plan view of a prior art needle-free connector
suitable for use with the instant invention;

[0033]FIG. 12b is a side elevation view of a prior art needle-free
connector suitable for use with the instant invention;

[0034]FIG. 12c is a bottom plan view of a prior art needle-free connector
suitable for use with the instant invention;

[0035]FIG. 12d is a cross section view of a prior art needle-free
connector suitable for use with the instant invention;

[0036]FIG. 13a is a top plan view of an embodiment of the instant
invention;

[0037]FIG. 13b is a side elevation view of an embodiment of the instant
invention;

[0038]FIG. 14a is a top plan view of an embodiment of the instant
invention; and

[0039]FIG. 14b is a side elevation view of an embodiment of the instant
invention.

DETAILED DESCRIPTION OF THE INVENTION

[0040]The molded container (10), see FIG. 4, of the instant invention
enables a significant advance in the state of the art. The detailed
description set forth below in connection with the drawings is intended
merely as a description of the presently preferred embodiments of the
invention, and is not intended to represent the only form in which the
present invention may be constructed or utilized. The description sets
forth the designs, functions, means, and methods of implementing the
invention in connection with the illustrated embodiments. It is to be
understood, however, that the same or equivalent functions and features
may be accomplished by different embodiments that are also intended to be
encompassed within the spirit and scope of the invention.

[0041]With reference generally now to FIGS. 1 through 14, the instant
invention comprises a molded container (10) with at least one diameter
(12), see FIG. 7, and a longitudinal axis (14), see FIG. 4. Such a
container would be most commonly formed according to the traditional
blow-fill-seal (BFS) methods described above. As seen in FIG. 3, and in
detail in FIG. 4, on its largest level, the container (10) comprises a
cap portion (300) and a body portion (200) with an encapsulated stopper
(100).

[0042]As seen in FIGS. 4 and 5, the container has a container shell (50)
comprising a body portion (200) with a body portion wall (220) having a
wall shoulder portion (221) having a distal aspect (222) and a proximal
aspect (223), best seen in FIG. 5. The terms "distal" and proximal" are
intended to represent positions relatively farther and relatively nearer,
respectively, from the longitudinal axis (14) of the container (10). The
body portion (200) has an adjoining cap portion (300), seen in FIG. 4,
having a cap portion wall (320), wherein the body portion wall (220)
meets the cap portion wall (320) at an engineered separation site (400),
seen in FIG. 4. The engineered separation site (400) is designed to
represent an area of weakness in the walls (220, 320) of the container,
such that a uniform and repeatable breakage area is created for the
removal of the cap portion (300) from the body portion (200).

[0043]The container (10) has a stopper (100), well seen in FIG. 5 and
shown in detail removed from the container in FIG. 6, enclosed within the
container shell (50), seen in FIG. 4, that prevents the transfer of
contents from the body portion (200) to the cap portion (300). A portion
of the stopper (100) is enclosed within the body portion (200) and a
portion of the stopper (100) is enclosed within the cap portion (300), as
seen in FIG. 4. The stopper (100) has a stopper wall (120) and a stopper
shoulder (123), see FIG. 6, with a central raised nipple (130) having a
nipple top surface (134) with an injection site (135) and a nipple
sidewall (132), as seen in FIG. 5. The engineered separation site (400),
see FIG. 4, is adjacent to the nipple sidewall (132) such that when the
cap portion (300) is removed from the body portion (200) at the
engineered separation site (400) a portion of the nipple (130) extends
out of the body portion (200), as seen in FIGS. 4 and 5.

[0044]This projection of a part of the nipple (130) beyond the body
portion (200) presents numerous advantages over the prior art. As
discussed above, the traditionally encapsulated stopper within a BFS vial
lies entirely within the shell of the BFS vial, as seen in FIG. 1 (prior
art). Thus, when the cap of such a vial is removed, the surface of the
stopper lies essentially in a hole formed by the surrounding BFS shell,
as seen in FIG. 2 (prior art). Thus, to clean the surface, it is
necessary to place a cleaning means into the hole, hoping that the means
will reach and adequately clean the surface of the stopper at the bottom
of the hole. Additionally, the relatively small hole means that the care
giver has only a very small surface area to hit with the needle, or other
removal means, used to puncture the stopper and access the container
contents.

[0045]The instant invention, as seen in FIG. 5, allows all of the top
surface (134) of the nipple (130) to be easily cleaned, if desired, and
allows substantially all of the top surface (134) of the nipple (130) to
be accessed by a needle, or other removal means, to puncture the stopper
(100) and access the container (10) contents. Additionally, in some
embodiments, the injection site (135) on the top surface (134) of the
nipple (130) is bounded by a raised injection guide (136) to assist in
correct placement of the needle or other removal means into the stopper
(100).

[0046]The body wall shoulder portion (221), adjacent to the cap portion
(300), may be configured at a non-orthogonal angle, seen in FIG. 5, from
the longitudinal axis (14) of the container (10). This also has numerous
advantages over the prior art. The traditional BFS vial, such as the
prior art examples seen in FIGS. 1 and 2, have shoulders over the
embedded stoppers that are configured approximately orthogonally to a
longitudinal axis of the container, resulting in approximately a
right-angle bend at the most lateral portion of the shoulder area. It can
be difficult, given such an orthogonal angle, to insure sufficient
plastic at the bend, to form a sufficiently strong container, using
traditional BFS methods. Additionally, such a right-angle bend imposes a
geometry that makes design of a suitable breakage line between the body
and the cap of a BFS vial more difficult. Both of these problems are
reduced with the instant invention, and in particular, the advantages
towards the design of a suitable breakage line will be discussed in more
detail below.

[0047]The instant invention may also be configured so that the body
portion wall (220) has an ingress preventer (224), seen in FIGS. 4 and 5,
wherein the ingress preventer (224) cooperates with a stopper ingress
preventer (124) formed in the stopper wall (120). Such cooperation
decreases the likelihood that the stopper (100) can be inadvertently
forced into the container (10) by external pressure. In another
embodiment, a wall retention surface (226) on the body portion wall (220)
cooperates with a stopper retention surface (126) on the stopper wall
(120). By way of example only, such cooperation may provide sufficient
frictional fit so that the stopper (100) is less likely to be forced
into, or expelled from, the container (10). In yet another embodiment,
also seen in FIG. 5, the wall retention surface (226) further comprises
at least one wall egress preventer (227), wherein the wall egress
preventer (227) cooperates with a stopper egress preventer (127) on the
stopper retention surface (126). Such cooperation reduces the chances of
the stopper (100) being inadvertently expelled from the container (10)
such as, by way of example only, might be caused by an over
pressurization of the interior of the container (10).

[0048]In another embodiment, the wall shoulder portion (221) further
comprises at least one raised gusset (228), seen in FIGS. 9b and 10,
extending from the wall shoulder portion (221) and having a lateral
surface (229) substantially parallel to the longitudinal axis (14) of the
container (10). Such gusset(s) (228) not only tend to strengthen the BFS
vial, but may cooperate with a variety of needle-free connectors, such
as, by way of example only, the SMARTSITE® needle-free connector
manufactured by Cardinal Health, Inc. of Dublin, Ohio, USA.

[0049]Extending the length of the lateral surface (229), see FIG. 9b,
increases the surface area of interaction between the lateral surface
(229) and the interior surface of a needle-free container, as can be seen
in FIGS. 10 and 11. A larger surface area for interaction results in a
more stable cooperation between the elements and a more positive
centering of a needle-free connector, as will be discussed immediately
below in relationship to FIGS. 8-11.

[0050]The advantage of the at least one raised gusset design may be seen
in FIGS. 8-11. In FIG. 8, a needle free connector (500), see FIG. 12a, of
the type, by way of example only, of the SMARTSITE® needle-free
connector poised at the moment of puncture of the injection site (135),
see FIG. 8, of the raised nipple (130). One skilled in the art can see,
as would be confirmed by reference to FIG. 9a, that it is relatively easy
for an operator to place the needle-free connector (500) eccentrically on
the container (10), potentially leading to an unstable connection and an
improper puncturing of the injection surface (135).

[0051]Typical features of a needle-free connector (500) may be seen in
FIGS. 12a-12d, as well as in FIGS. 8, 9a, and 10-11. As seen in FIGS. 10
and 12a-d, some of the features of a typical needle-free connector
include a connector male end fluid port ingress regulator (523),
essentially shaped as a spike-like means for puncturing the stopper (100)
at the injection site (135) and a connector male end fluid port interlock
(524), essentially configured as resilient clips that allow the
needle-free connector (500) to cooperate with various configurations of
the body portion (200) of the container (10).

[0052]The effect of the raised gusset (228) design, particularly
embodiments employing a lateral surface (229) substantially parallel to
the longitudinal axis of the container (10), may be appreciated by one
skilled in the art as illustrated in FIG. 10. As the needle-free
connector approaches the top of the container (10), the raised gusset(s)
(228), particularly the lateral edges (229), interacts with the clip-like
sides of the needle-free connector. This tends to guide the needle-free
connector to a proper central placement on the injection site (135).
Additionally, as can be seen in FIG. 11, the raised gusset(s) (228) tend
to fill the interior volume of the needle-free connector and to insure a
closer and more stable fit with the body portion (200) of the container
(10). The details of a typical needle-free container suitable for use
with the instant invention are shown, by way of example only, in FIGS.
12a-d.

[0053]As seen in FIGS. 13a-b and 14a-b, to assist in the separation of the
cap portion (300) and the body portion, the cap portion (300), see FIG.
7, may have a cap portion wall (320) formed with a grip enhancing feature
(330). Such a grip enhancing feature (330) may be a flattened tab (332)
having a lateral aspect (333). Various embodiments employing different
geometries maybe useful in facilitating the opening of the container (10)
which is often of a relatively small size. By way of example only, the
grip enhancing features may be a flattened tab (332) attached to the cap
portion (300), seen in FIGS. 13a-b and 14a-b. Such a flattened tab (332)
may have relatively short lateral expanse such that the easiest means of
removing the cap portion (300) from the body portion (200) is to use two
hands, one to grip the body portion (200) and another to twist off the
cap portion (300). Such a twisting motion is shown in FIG. 13b by the
two-headed arrow indicating rotation that is shown on the cap portion
(300). While one-handed removal of the cap portion (300) in such a design
is not impossible, it may require a degree of hand strength not
universally found among those desiring to use the container (10). It may
be desirable to facilitate one-handed removal of the cap portion by
altering the geometry of the tab (332).

[0054]The hand strength required for one-handed opening may be decreased
by increasing the moment arm of the tab (332) that is, the larger the tab
(332) relative to the container (10), the less force that must be applied
at a distal point on the tab (332) to effect a rupture at the engineered
separation site (400). By way of example, a tab (332) is shown in FIGS. 7
and 14b formed such that a distance from a most distant point on the tab
(332), at the lateral aspect (333), from a center of the injection site
(135) is at least 50% of the largest of the at least one diameter (12) of
the container (10). A similar construction may be seen in FIG. 14b. This
allows easier removal of the cap portion (300) from the body portion
(200) by simply torquing the cap portion (300), in the direction shown by
the single headed arrow on the cap portion (300) seen in FIG. 14b. In a
further embodiment, the tab (332) is formed such that a distance from a
most distant point on the tab (332), at the lateral aspect (333), from a
center of the injection site (135) is at least 65% of the largest of the
at least one diameter (12) of the container (10), as may be seen in FIG.
7 and FIG. 14b. Such relative elongation of the tab (332) simply
increases the leverage available for opening the container (10) at the
engineered separation site (400).

[0055]Clean and accurate removal of the cap portion (300) from the body
portion (200) may also be facilitated by refinements in the engineered
separation site (400) where the body portion wall (220) meets the cap
portion wall (320). Such a site (400) could comprise, by way of example,
a score line in the shell wall (52). In one embodiment of the instant
invention, as seen in FIGS. 4 and 5, the engineered separation site (400)
comprises a line of discontinuity in shell thickness between the body
portion wall (220) and the cap portion wall (320). The discontinuity
creates a natural fracture zone between the adjoining body portion (200)
and cap portion (300). As seen in FIG. 5, in a further embodiment, the
engineered separation site (400) is formed by a progressive attenuation
of the thickness of the wall shoulder portion (221), see FIG. 5, tapering
from a maximum thickness at the distal aspect (222) of the wall shoulder
portion (221) to reach a minimum thickness at the proximal aspect (223)
of the wall shoulder portion (221).

[0056]Numerous alterations, modifications, and variations of the preferred
embodiments disclosed herein will be apparent to those skilled in the art
and they are all anticipated and contemplated to be within the spirit and
scope of the claimed invention. For example, although specific
embodiments have been described in detail, those with skill in the art
will understand that the preceding embodiments and variations can be
modified to incorporate various types of substitute and or additional or
alternative materials, relative arrangement of elements, and dimensional
configurations. Accordingly, even though only few variations of the
present invention are described herein, it is to be understood that the
practice of such additional modifications and variations and the
equivalents thereof, are within the spirit and scope of the invention as
defined in the following claims.

INDUSTRIAL APPLICABILITY

[0057]The container with a raised nipple of the instant invention answers
a long-felt need in the area of BFS containers having internally
encapsulated stoppers. The design of the invention allows a portion of
the raised nipple to extend beyond the body portion of the container,
after opening, such that it may be easily accessed and cleaned.
Additional modifications, including the provision of an improved
engineered separation site at the point of opening, and raised gussets
that may provide a secure connection with various needle-free connectors
improves the safety and efficiency found in this art.